3 Upgrade preparations

Organizations need to plan to transition from the old dosage forms list to adopt Standard terms list provided by EDQM, according to the ICH User Guide: Use of EDQM terminologies for Dose Forms and Routes of Administration for Individual Case Safety Reports in E2B(R3) message July 2020 version 1.1.

For more information, see:

• General preparations
  ICH recommends providing the following data to represent EDQM terminology for Dose Form and Route of Administration.
• Pre-upgrade preparations
  To ensure that the desired RoA and Formulations are available for case processing, organizations need to prepare with the following activities.
• Post-upgrade
  After upgrade, take the following steps to ensure that the terms for the Routes of Administration and Formulation codelist are correct.
• Periodic upgrade of EDQM Standard Term list
  Organizations need to update the safety systems regularly to get revised terms published by EDQM.